Oral Temperature Digital Thermometer 16811

GUDID 20612606001516

Dual Scale Oral Digital Thermometer, 60 second read

KERMA MEDICAL PRODUCTS, INC.

Intermittent electronic patient thermometer
Primary Device ID20612606001516
NIH Device Record Key960ae9c9-a430-45b8-b4b8-20083d97dfe4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOral Temperature Digital Thermometer
Version Model Number16811
Catalog Number16811
Company DUNS787328772
Company NameKERMA MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100612606001512 [Primary]
GS120612606001516 [Package]
Contains: 00612606001512
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-18

On-Brand Devices [Oral Temperature Digital Thermometer]

20612606001523Dual Scale Oral Digital Thermometer with 20 Probe Covers, 60 second read
20612606001516Dual Scale Oral Digital Thermometer, 60 second read

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